IMPLEMENTATION GUIDE
Use of ISBT 128 in
Resource-Limited Countries
Version 1.0.0
August 2016
Tracking Number ICCBBA IG-041
Published by:
ICCBBA
PO Box 11309, San Bernardino, CA 92423-1309 USA
Use of ISBT 128 in Resource-Limited Countries v1.0.0
2
Warranty Disclaimer and Limitation of Liability
ICCBBA provides no representation or warranty that the Licensee’s use of ISBT 128 is
suitable for any particular purpose and the selection, use, efficiency and suitability of ISBT
128 is the sole responsibility of the Licensee. ICCBBA is not an accrediting organization and
is not responsible for adherence to the standard, the selection of product codes, or product
labeling by facilities registered for its use
ICCBBA’s liability is limited to that specified in the ICCBBA License Agreement which is
available on the ICCBBA website. Under no circumstances shall ICCBBA’s liability to
licensee or any third party under any theory or cause of action exceed the current annual
license fee payable by the licensee to ICCBBA hereunder, and ICCBBA will in no
circumstances be liable for any direct or indirect damages whatsoever, including without
limitation special, incidental, consequential, or punitive damages or damages for loss of
data, business or goodwill or any other consequential losses of any nature arising from the
use of ISBT 128 or the marks.
COPYRIGHT NOTICE
Copyright 2016. ISBT 128 is not in the public domain and is protected by law.
Implementation of ISBT 128 requires the end-user to register with ICCBBA and to pay an
annual license fee. License fees are established by the ICCBBA Board of Directors to cover
the expenses of maintaining and extending ISBT 128, and making available current versions
of the documents and database tables that are needed to implement this Guidance.
Any use of this Guideline, or the accompanying database tables, by other than registered
organizations, or facilities that have obtained their computer software from a registered and
licensed developer, is strictly forbidden. Copying any portion of the Standard, or of any
accompanying database table, either in electronic or other format, without express written
permission from ICCBBA is strictly forbidden. Posting of any portion of the Standard, or of
any accompanying database table, to any online service by anyone other than ICCBBA is
strictly forbidden.
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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Editor
Pat Distler, MS, MT(ASCP)SBB
Technical Expert, ICCBBA
Standards Committee
John Armitage, Prof., BSc, PhD
United Kingdom
Paul Ashford, MSc. CEng. CSci.
ICCBBA
Wayne Bolton, B.App.Sc., M.App.Sc
Australia
Suzanne Butch, MA, MT(ASCP)SBB
United States of America
Erwin Cabana, BA
ICCBBA
Pat Distler, MS, MT(ASCP)SBB
ICCBBA
Jørgen Georgsen, MD
Denmark
Suzy Grabowski, BA, BB(ASCP)SBB
United States of America
Mario Muon, MD
Portugal
Stefan Poniatowski, BSc, MIBMS
Australia
Leigh Sims Poston, BS, MT(ASCP)
United States of America
Ineke Slaper-Cortenbach, PhD
The Netherlands
Zbigniew Szczepiorkowski, MD, PhD, FCAP
United States of America
Izabela Uhrynowska-Tyszkiewicz, MD, PhD
Poland
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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Table of Contents
Forward...................................................................................................................................... 8
1
2
3
Introduction ......................................................................................................................... 9
1.1
Purpose ....................................................................................................................... 9
1.2
Scope .......................................................................................................................... 9
1.3
Intended Audience ....................................................................................................... 9
1.4
Normative References ................................................................................................. 9
1.5
Other References ........................................................................................................ 9
1.6
Background.................................................................................................................10
1.7
Definitions of Terms Referring to Facilities ..................................................................11
Traceability ........................................................................................................................12
2.1
Concepts ....................................................................................................................12
2.2
ISBT 128 and Traceability ...........................................................................................12
2.2.1
Donation Identification Number (DIN) ..................................................................12
2.2.2
Product Code .......................................................................................................13
Information Environment ....................................................................................................15
3.1
Interoperability ............................................................................................................15
3.2
ISBT 128 Environment ................................................................................................15
4
Terminology .......................................................................................................................16
5
Coding ...............................................................................................................................17
5.1
5.1.1
Donation Identification Number [Data Structure 001] ...........................................18
5.1.2
ABO/RhD [Data Structure 002] ............................................................................20
5.1.3
Product Code [Data Structure 003] ......................................................................21
5.1.4
Expiration Date and Time [Data Structure 005] ....................................................22
5.1.5
Collection Date [Data Structure 006] ....................................................................23
5.2
6
Data Structures ...........................................................................................................17
Reference Tables .......................................................................................................24
5.2.1
ABO/RhD .............................................................................................................24
5.2.2
Product Codes .....................................................................................................26
Labeling .............................................................................................................................31
6.1
Electronically-Readable Information ............................................................................31
6.1.1
Delivery mechanisms ...........................................................................................31
6.1.2
Concatenation......................................................................................................32
6.1.3
Coding of Information within Electronically-Readable Symbols ............................33
6.2
Label Design ...............................................................................................................34
6.2.1
Role of regulations and other standards...............................................................34
6.2.2
Principles .............................................................................................................34
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6.2.3
6.3
Quadrant design ..................................................................................................34
Text ............................................................................................................................37
6.3.1
Eye-Readable Text ..............................................................................................37
6.3.2
DIN ......................................................................................................................38
6.3.3
ABO/RhD and Special Message Text ..................................................................39
6.3.4
Product Information Text ......................................................................................41
6.3.5
Expiry Date and Time Text...................................................................................41
6.4
7
5
Label Options..............................................................................................................42
6.4.1
Purchasing Preprinted Labels ..............................................................................42
6.4.2
On-Demand Labels ..............................................................................................51
ISBT 128 in the Hospital Blood Bank .................................................................................55
7.1
Essential Records .......................................................................................................55
7.1.1
DIN ......................................................................................................................55
7.1.2
Product Information..............................................................................................57
7.1.3
ABO/RhD .............................................................................................................58
7.1.4
Expiry date ...........................................................................................................58
7.1.5
Linking Product Information to Recipient Information ...........................................59
7.2
Modification of Products ..............................................................................................59
7.2.1
Expiry Dates ........................................................................................................60
7.2.2
Product Code .......................................................................................................60
8
Back-up Systems ...............................................................................................................63
9
Hemovigilance ...................................................................................................................64
10
Registration and Licensing with ICCBBA ........................................................................65
11
Conclusion .....................................................................................................................66
11.1
Flexibility .....................................................................................................................66
11.2
More information and technical support ......................................................................66
Acronyms ..................................................................................................................................67
Glossary....................................................................................................................................68
Appendix 1 Example Implementation Plan ...............................................................................72
Appendix 2 Options for Implementing ISBT 128 .......................................................................74
Appendix 3 Example Labels ......................................................................................................78
Figures
Figure 1 Donation Identification Number (DIN) .........................................................................13
Figure 2 Product Code .............................................................................................................13
Figure 3 Information Environment ............................................................................................15
Figure 4 Data Structure ............................................................................................................17
Figure 5 Donation Identification Number Data Structure ..........................................................18
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Figure 6 ABO/RhD Data Structure ...........................................................................................21
Figure 7 Product Code Data Structure for a Blood Product ......................................................22
Figure 8 Product Code of a Divided Product ............................................................................22
Figure 9 Expiration Date and Time ...........................................................................................23
Figure 10 Collection Date [Data Structure 006] ........................................................................23
Figure 11 Collection Date and Time [Data Structure 007] .........................................................24
Figure 12 ABO/RhD Data Structure .........................................................................................25
Figure 13 Encoding a Special Message ...................................................................................26
Figure 14 Product Code Data Structure ...................................................................................26
Figure 15 Example Product Description Code ..........................................................................27
Figure 16 Example of Division Code ........................................................................................30
Figure 17 Use of Division Codes for Two Division Levels ..........................................................30
Figure 18 Comparison of 2-D (Data Matrix) and Linear (Code 128) .......................................... 32
Figure 19 Quadrant Design of Blood Label ..............................................................................35
Figure 20 Location of Bar Codes ..............................................................................................36
Figure 21 ISBT 128 Final Blood Label ......................................................................................36
Figure 22 Blood Group Label ...................................................................................................37
Figure 23 Text Presentation of DIN ..........................................................................................38
Figure 24 Emphasis of Sequence Number in DIN ....................................................................39
Figure 25 Adding Spaces in Sequence Number .......................................................................39
Figure 26 Group O, RhD Positive Label ...................................................................................40
Figure 27 Some Options for RhD Negative Labels ...................................................................40
Figure 28 Example Special Message Label .............................................................................40
Figure 29 Piggy Back DIN Labels.............................................................................................43
Figure 30 Tear-Off Label ...........................................................................................................44
Figure 31 Preprinted Upper Left Quadrant ...............................................................................45
Figure 32 Upper Left Quadrant after Addition of DIN and Collection Date ................................ 46
Figure 33 100 mm by 100 mm Initial Label...............................................................................46
Figure 34 Preprinted Upper Right Quadrant Label ...................................................................47
Figure 35 Preprinted Lower Left Quadrant ...............................................................................47
Figure 36 Lower Left Quadrant with Handwritten Information ...................................................48
Figure 37 Lower Right Quadrant ..............................................................................................48
Figure 38 Use of Preprinted Labels ..........................................................................................49
Figure 39 Assembly of Preprinted Labels .................................................................................49
Figure 40 Label Created Using Preprinted Quadrant Labels ....................................................50
Figure 41 Labeling Using 100 mm x 100 mm “Over-lay” Label .................................................53
Figure 42 Donation Identification Number ................................................................................55
Figure 43 Location of DIN on ISBT 128 Label ..........................................................................55
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Figure 44 Label with Tear-Off Portion for Patient Record .........................................................56
Figure 45 Location of Product Information on ISBT 128 Label ..................................................57
Figure 46 Location of Product Division Information on ISBT 128 Label .................................... 58
Figure 47 Placement of ABO/Rh and Expiry Date .....................................................................59
Figure 48 Replacing Lower Half of the Label for Thawed Plasma ............................................ 61
Figure 49 Full Label .................................................................................................................78
Figure 50 Examples of Upper Right Quadrant ..........................................................................78
Figure 51 Examples of Lower Left Quadrant Labels .................................................................79
Figure 52 Examples of Lower Right Quadrant Labels ..............................................................79
Tables
Table 1 Excerpt of ABO/RhD Reference Table for Data Structure 002 ..................................... 24
Table 2 Special Messages Used in Data Structure 002............................................................25
Table 3 Product Description Codes Reference Table ...............................................................28
Table 4 Collection Type ...........................................................................................................29
Table 5 Excerpt from Type of Collection Reference Table [RT008] .......................................... 38
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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Forward
To meet the vision of the International Council for Commonality in Blood Bank Automation
(ICCBBA) of global adoption of ISBT 128 for all medical products of human origin, it is
necessary to take into consideration the time and costs associated with the implementation of a
new coding and labeling system. As these factors are very important in a facility’s decision to
implement a new system, consideration must be given to facilities located in countries at
different levels of development and with limited resources for implementation of such a
standard.
Because of these considerations, ICCBBA has created this guidance document to supplement
ISBT 128 Standard Technical Specification (ST-001) that limits features within the standard to
those that are required to improve traceability and recipient safety, while reducing time and
costs associated with full implementation.
Specifically, this guidance document is targeted to the Blood Transfusion Service (BTS) and
Hospital Blood Bank (HBB) staff that are operating in resource-limited countries. Important
topics include:
•
•
•
•
•
•
Traceability (Chapter 2, page 12)
Interoperability (Section 3.1, page 15)
The ISBT 128 Standard
o Standardized Terminology (Chapter 4, page 16)
o Coding (Chapter 5, page 17)
o Labeling (Chapter 6, page 31)
Hemovigilance (Chapter 9, page 64), and
Flexibility (Section 11.1, page 66)
Options for implementing ISBT 128 (Appendix 2)
To facilitate creation of this guidance document, ICCBBA staff visited a BTS and several HBBs
located in a low Human Development Index country (as classified by the United Nations
Development Program). Valuable information was shared and assessments were made based
on the needs and resources of these facilities. This document reflects the results of that visit
and provides recommendations for how the ISBT 128 standard can be flexed to meet users’
needs. Of interest is Appendix 2, where different options for implementation are discussed,
including relative costs, advantages, and disadvantages for each option.
For more information, contact the ICCBBA office at [email protected] or visit us on the web at
www.iccbba.org.
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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1.1
9
Introduction
Purpose
The purpose of this document is to provide guidance for implementation of the ISBT 128
Standard for blood transfusion in resource-limited countries. It is intended to provide
options allowing facilities to promote safety, traceability, and efficiency without needing
to implement all features of the ISBT 128 Standard.
1.2
Scope
This document is a supplement to the ISBT 128 Standard Technical Specification. The
scope of this document is limited to those features of ISBT 128 that may be used by
blood banking facilities with limited resources to improve traceability and recipient safety.
It is not intended for use by facilities in countries rated as high or medium in the United
Nation’s Human Development Index (HDI) (http://hdr.undp.org/en/composite/HDI). It is
also limited to whole blood and blood components.
The first two chapters of this document address two general concepts: Traceability, a
requirement for all medical products of human origin (MPHO), and the information
environment that is needed for good record keeping to support traceability in the
electronic age. Subsequent chapters will discuss ISBT 128 in more detail. Finally,
Chapter 8 returns to a general concept, hemovigilance.
1.3
Intended Audience
The intended audience of this document is Blood Transfusion Service (BTS) and
Hospital Blood Bank (HBB) staff including management, information technology, quality,
validation, and laboratory, in resource-limited countries.
1.4
Normative References
ISBT 128 Standard Technical Specification (ST-001)
ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002)
ISBT 128 Standard Labeling of Blood Components (ST-005)
ISBT 128 Standard Product Description Code Database (ST-010).
ISO 8601 (2004)(E) Data elements and interchange formats — Information interchange
—Representation of dates and times
1.5
Other References
ICCBBA Website (www.iccbba.org)
ISBT 128, An Introduction to Bar Coding (IN-009)
Technical Note 2, Length of the Product Code Bar Code and Concatenation (IG-017)
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Technical Bulletin 5, Bar Code Scanner ISBT 128 Concatenation (IG-008)
Implementation Guide: Use of Data Matrix Symbols with ISBT 128 (IG-014)
Implementation Guide: Use of the Product Code [Data Structure 003] – Blood (IG-021)
Implementation Guide: Choosing an On-Demand Label Printer (IG-029)
Implementation Guide: Use of the Donation Identification Number [Data Structure 001]
(IG-033)
Recommendations WHO Global Consultation on Haemovigilance. Global Consultation
on Haemovigilance, Dubai, 20-22 November 2012. Available from
http://www.who.int/bloodsafety/haemovigilance/global_consultation/en/ Accessed 28
December 2015.
Resolution WHA63.22. Human organ and tissue transplantation. In: Sixty-third World
Health Assembly, Geneva, 17–21 May 2010. Volume 1. Resolutions and decisions.
Geneva: World Health Organization; 2010 (WHA63/2010/REC/1). Available from:
http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R22-en.pdf Accessed 28 Dec 2015.
WHO EB136-32 (third bullet of ‘the way forward’ applies). Bull World Health Organ
013;91:314–314A WHO Aide-Memoire on Haemovigilance
http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_32-en.pdf
AfSBT Step-Wise Accreditation Standards, Africa Society for Blood Transfusion (AfSBT),
2013.
Guidance Document, Step-Wise Accreditation Programme, Africa Society for Blood
Transfusion (AfSBT), 2013.
1.6
Background
There is growing recognition of the need for standardization of terminology, coding, and
labeling of all MPHO in order to improve traceability and transparency. The 2010 World
Health Assembly Resolution WHA63.22 called on member states to “encourage the
implementation of globally consistent coding systems for human cells, tissues and
organs as such in order to facilitate national and international traceability of materials of
human origin for transplantation.” ICCBBA is working with WHO in order to achieve this
objective using the ISBT 128 Information Standard. On its Website
(http://www.who.int/transplantation/tra_isbt/en/), WHO describes ISBT 128 as the sole
global standard for the identification and coding of MPHO.
A Specification, ISBT 128, for labeling blood products was developed by the
International Society of Blood Transfusion Working Party on Automation and Data
Processing [now called the Working Party on Information Technology] and published by
ICCBBA in 1995. Around the world, implementation in blood establishments began soon
after the standard was issued, with a steady increase in adoption since that time. Many
countries around the world now use ISBT 128 for blood and there is a steady global
movement toward implementation of ISBT 128 for cells, tissues, and other MPHO.
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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ISBT 128 labeling allows each product to be uniquely identified on a global scale. This
supports traceability, which in turn supports vigilance and surveillance. However, ISBT
128 is more than a labeling system. It addresses three related, but distinct, areas:
terminology, coding, and labeling.
International standardization of terminology and product coding is a key element of ISBT
128. Standardized product coding allows blood products to be shipped internationally
with clear, unambiguous labeling. Language barriers can be overcome through the use
of standardized bar codes and a shared ICCBBA-maintained database.
ISBT 128 is managed by ICCBBA, a non-profit nongovernmental organization in official
relations with the WHO based in the US. It provides a technical help desk (email
[email protected]) to answer questions and to help users implement the standard.
Additionally, a great deal of information, including ICCBBA documents and databases,
are found on its Website (www.iccbba.org).
1.7
Definitions of Terms Referring to Facilities
Throughout this document, the following terms will be used with these definitions:
Blood Transfusion Service
(BTS)
Hospital blood bank (HBB)
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An organization, or department within an
organization, that is responsible for any aspect of the
collection and testing of human blood or blood
components, whatever their intended purpose, and
their processing, storage, and distribution when
intended for transfusion (excludes hospital blood
bank).
A hospital unit which stores and distributes, and may
perform compatibility tests on, blood and blood
components exclusively for use within hospital
facilities. It includes hospital-based transfusion
activities. An HBB may also be referred to as hospital
transfusion laboratory.
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2.1
12
Traceability
Concepts
Traceability in blood banking involves the ability to track a blood product from donor to
recipient and from recipient to donor, and to track from any blood product to all the other
blood products derived from the same donation. The concept of traceability is central to
the management of all medical products of human origin (MPHO), which include blood,
tissues, organs, cellular therapy products, and human milk. Requirements for traceability
are frequently embedded in regulations as well as in standards formulated by
professional societies. While the principles of traceability apply to all MPHO, this
document will focus on blood and blood components.
Two requirements must be met to ensure traceability:
•
Unique Identifiers: Each unit of blood or blood component must be uniquely
identified in order to create an unambiguous path between donor and recipient.
•
Good record keeping: Because an adverse event can occur soon after
transfusion or it may be recognized years later, reliable systems must exist to
accurately record and store information about the source and disposition of the
blood component, as well as the path the product takes between donor and
recipient, for many years.
Together, these requirements mean that facilities must assign identifiers to products that
are unique for a long period of time and develop mechanisms to ensure these identifiers
are transcribed and recorded accurately at each point in the transfusion chain. The
actual length of time for which an identifier must remain unique will vary by national
regulations.
2.2
ISBT 128 and Traceability
Implementation of the ISBT 128 Standard facilitates traceability by providing the
mechanism for uniquely identifying each product for a period of 100 years and by
supporting automation of information capture and record keeping by making key
traceability information electronically readable (bar coded). Chapters 3 and 5 will discuss
how information is encoded for use in bar codes.
To uniquely identify each blood product, ISBT 128 requires two elements, the Donation
Identification Number and the Product Code.
2.2.1
Donation Identification Number (DIN)
An ISBT 128 DIN uniquely identifies a donation event and links the unit to the
donor in the facility records. (Note: A DIN may also be used to identify a
product pool. This is discussed in 7.2.2 in the section on Pooled Products.) It
comprises three elements:
• A 5-character facility identification number that is assigned by
ICCBBA to ensure global uniqueness.
• A 2-character year code that represents the year the DIN was
assigned and ensures uniqueness for a 100-year period.
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
•
13
A 6-character sequence number assigned by the facility to ensure
uniqueness during the year indicated.
Figure 1 Donation Identification Number (DIN)
For more information about coding the DIN into an electronically-readable
format, see Section 5.1.1. For text presentation of the DIN on the product
label, see 6.3.2.
2.2.2
Product Code
A product code uniquely identifies different products from the same donation
(e.g., Red Cells, Plasma, and Platelets from the same donation). The product
code has 8 characters and comprises three elements:
•
•
•
A 5-character Product Description Code that indicates the type of
product (red cells, plasma, platelets, etc., and may include details
such as storage temperature and anticoagulant)
A 1-character donation type code (allogeneic, autologous, directed,
replacement, etc.)
A 2-character division code (to uniquely identify multiple aliquots from
the same donation and with the same Product Description Code).
Figure 2 Product Code
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
14
For more information about coding the product information into an
electronically-readable format, see Section 5.1.3. For printing product
information as text, see Section 6.3.4.
Each blood component is assigned a DIN and a Product Code that work in a hierarchical
manner:
•
•
The DIN uniquely identifies a collection event and appears on all products from
that collection. Once assigned to products, the DIN should never change. It is the
link to the donor. (Note: A DIN may also be used to identify a product pool. This
is discussed in 7.2.2 in the section on Pooled Products.)
The Product Code uniquely identifies each product that results from the
collection. The Product Code will change if the product is modified or divided.
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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3.1
15
Information Environment
Interoperability
Interoperability is the property of a system that allows it to be used across disparate
computer systems. This is an important feature of a blood bank coding system because
(1) it supports sharing of blood resources and (2) it means blood bank software does not
need to be customized for each organization. ISBT 128 provides interoperability for the
over 5000 facilities licensed for its use worldwide.
3.2
ISBT 128 Environment
The information environment comprises a number of layers each of which needs to be in
place to ensure that standardization can be achieved. ISBT 128 is a terminology, coding,
and labeling system. This can be broken further into the elements shown in Figure 3.
The next three chapters will look at these elements in more detail.
Figure 3 Information Environment
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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16
Terminology
Standardized product terminology is the foundation of the ISBT 128 coding system. For bar
codes to have a standardized meaning, users must first agree upon what to call a product. This
is not as easy as it may seem, given the diversity of the use of ISBT 128 both geographically
and across different MPHO. ICCBBA, the organization that manages the ISBT 128 Standard,
organizes experts from various fields (blood, cells, tissues, human milk, etc.) into Technical
Advisory Groups (TAGs). These experts work together to propose terms and definitions which
are then released for public comment. When consensus is reached, terminology is published in
the document ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002)
and used to describe products within the ISBT 128 system.
For a complete list of terms and definitions, see ISBT 128 Standard Terminology for
Medical Products of Human Origin (ST-002).
This agreed terminology is used to describe blood products in terms of Classes, Modifiers, and
Attributes.
For a detailed description of how the system works, see Implementation Guide, Use
of the Product Code [Data Structure 003] – Blood (IG-021).
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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5.1
17
Coding
Data Structures
Data structures are the means by which information about blood components is put into
computer-friendly codes. Data structures define the technical characteristics necessary
for the interpretation of the information. They specify the context and structure and
provide the links to the appropriate reference tables for conversion of codes into
meaningful information.
Data structures comprise two elements:
•
•
Data identifier: a two- or three-character code that identifies the data structure
[described in more detail in the ISBT 128 Standard Technical Specification (ST001)].
Data content: the data characters that provide the information to be conveyed
(e.g., coded information that conveys the product is Red Blood Cells).
Figure 4 Data Structure
ISBT 128 data structures may be used in bar codes on labels of blood components for
electronic communication or may be used for electronic messaging between computers.
There are many ISBT 128 data structures not all of which will be used in the labeling of
blood. A description of all ISBT 128 data structures is found in ISBT 128 Standard
Technical Specification (ST-001). Each data structure is identified with a number in
brackets after the name of the data structure. Data structures that are required for
traceability are:
•
•
Donation Identification Number [Data Structure 001]
Product Code [Data Structure 003]
Other data structures that are needed for blood banks, but that are not essential to
traceability, include:
•
•
•
ABO/RhD [Data Structure 002]
Expiration Date and Time [Data Structure 005]
Collection Date [Data Structure 006] or Collection Date and Time [Data Structure
007]
This chapter will include a high level description of these data structures. Specific details
of coding are found in the ISBT 128 Standard Technical Specification (ST-001).
Guidance on how and when to use these data structures appears later in this document
and/or in one of the documents referenced in Sections 1.4 or 1.5.
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
5.1.1
18
Donation Identification Number [Data Structure 001]
Data Structure 001 specifies a Donation Identification Number (DIN) that is a
unique identification of a donation/recovery event or product pool from
anywhere in the world over a one hundred year period.
This data structure is unique in that the second character of the data identifier
also serves as the first character of the data content.
Figure 5 Donation Identification Number Data Structure
The DIN contains three elements:
•
The first element, the Facility Identification Number (FIN), is assigned
to a facility by ICCBBA and supports global uniqueness. In order to
obtain a FIN, blood banks will need to register with ICCBBA. ICCBBA
maintains a database of code assignments and this table is available
to licensed users of the ISBT 128 system. It is called “Registered
Facilities” and is found in a password-protected area of the ICCBBA
Website (www.iccbba.org). The FIN within the DIN identifies the
organization that assigned the DIN.
•
The second element is a two-digit year and supports uniqueness for a
100-year period. This is a nominal year identifier and should not be
used as an alternative to other date data structures (such as
Collection Date, Expiration Date and Time, etc.). Its purpose is solely
to support the requirement for 100 year uniqueness. Note: In practice,
this is the “nominal” year. To cut down on wastage, DIN labels may be
used for up to one month in the year before, and one month in the
year after, the year shown on the label.
•
The third element is a sequence number assigned by the facility. The
facility is responsible for ensuring the sequence number is unique to
each collection/recovery event or product pool for a given year and
FIN.
Together, the three elements create global uniqueness for the DIN.
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Sequence Number
A facility can determine how a sequence number is assigned. For
example, it can start at 000001 at the beginning of each year. That
is, it can start at 000001 when it first starts to use 17 as the year
code, number sequentially through the year, and then start again
at 000001 when it begins to use DINs with a year code of 18.
However, this is not essential.
Scenario 1: If the BTS prints its own DINs, it can assign the next
sequential number when a new year code is used. For example, if
the BTS ends 2016 with the sequence number 019598 which
appears as:
A9997 16 019598
It could start 2017 using the next sequential number for the
sequence number which would be:
A9997 17 019599
Scenario 2: If a BTS has its labels printed by a commercial
company, and it collects fewer than 100,000 units of blood each
year, it could vary the first character of the sequence number each
year.
Following this plan, if facility began using ISBT 128 in 2016, the
first sequence number would be:
A9997 16 000001
And thereafter the DINs would be assigned in sequential order.
It could then start 2017 with the sequence number 100001 which
would then appear as:
A9997 17 100001
2018 would start with the sequence number 200001 which would
appear as:
A9997 18 200001
For more information on how the sequence number can be used
to support facility operations, contact the ICCBBA help desk at
[email protected].
Flag Characters
It is not recommended that flag characters be adopted during the
initial implementation of ISBT 128 in resource-limited countries.
However, this decision is left to each facility. Flag characters, used
for process control, are a part of the DIN data structure, but are
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not a part of the DIN itself. These characters allow a facility to
indicate where a bar coded DIN appeared (e.g., on the product
label, a sample test tube, or a donor record) and can be used to
facilitate automated process control. These flag characters are
optional and, if not needed, the flag value of “00” should be used.
Systems receiving ISBT 128 labeled products should accept any
valid final product flag characters.
The meaning of some of the values have been standardized while
the meaning of others may be assigned by the facility.
For more information on flag characters, see ISBT 128
Standard Technical Specification (ST-001).
Check Character
Although not a part of the data structure (and the bar coded
information), a check character is added to the end of the DIN to
support verification of correct keyboard entry. This check
character is calculated following MOD 37-2 within ISO/IEC
7064:2003(E).
The check character may be any one of the thirty seven
characters in the set (0-9, A-Z, asterisk). Where computer systems
accept manual entry of a DIN, the check character should always
be a required part of the entry and software should verify the
character is correct.
For more information about the check character, see
Implementation Guide: Use of the Donation Identification
Number [Data Structure 001] (IG-033).
5.1.2
ABO/RhD [Data Structure 002]
Blood Groups are encoded using the first two data content characters of the
ABO/RhD data structure. The third character of this data structure is
sometimes used to encode other blood group antigens (C, c, E, e; K; or
Miltenberger antigens), but it is not recommended that this coding be adopted
on initial implementation of ISBT 128 in resource-limited countries. This third
character should be set to the default, 0. The fourth character of the data
structure has been set aside for future use and should always be set to 0.
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Figure 6 ABO/RhD Data Structure
This data structure can also be used to encode special messages when
encoding the ABO/RhD is not needed. For example, one such message is:
“Discard (to be destroyed)” and another is “Quarantine/hold for further testing
or processing.” This is discussed further in Section 6.3.3 on page 39.
5.1.3
Product Code [Data Structure 003]
Data Structure 003 uniquely identifies a product intended for human use. The
Product Code contains three elements:
•
A 5-character Product Description Code (PDC) is assigned by ICCBBA to
each product description. Products are described using terminology
created by expert advisory groups such as the Europe, Middle East and
Africa Technical Advisory Group (EMATAG). These groups utilize a
scheme of Classes (broad descriptions of product such as Red Blood
Cells or Platelets), Modifiers (the next level of detail such as Apheresis or
Frozen), and Attributes (the next level of detail such as irradiation or
dosage) to describe products. Each product is described minimally with a
Class and may also have a Modifier or one or more Attributes.
Detailed information on creating PDCs may be found in
Implementation Guide: Use of Product Code [Data Structure
003] – Blood (IG-021).
A database, called the ISBT 128 Product Description Codes Database,
lists all assigned codes and the corresponding product descriptions. The
database is found in a password-protected area of the ICCBBA Website
(www.iccbba.org) and is accessible by licensed users.
•
A one-character Collection Type Code that allows facilities to encode the
type of collection (e.g., autologous or allogeneic).
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22
A 2-character Division Code that allows each product with the same DIN
and PDC to be uniquely identified. For example, if a unit of Red Blood
Cells is divided, both portions will have the same DIN and PDC. To be
able to trace each product separately, they must be uniquely identified by
giving each a different division code. See Figure 8. More information is
found in Section 5.2.2.3.
Figure 7 Product Code Data Structure for a Blood Product
Figure 8 Product Code of a Divided Product
5.1.4
Expiration Date and Time [Data Structure 005]
While having an electronically-readable expiry date is not required, it can
enhance safety and accuracy. This data structure uses the last three
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numbers of the year (e.g., 2017 becomes 017 in the code); the ordinal
number of the calendar year (or Julian, date) where the days of the year are
numbered sequentially beginning with 001 on January 1; and the time based
on a 24-hour clock. If the product expires at midnight, 2359 (23:59 or 11:59
p.m.) is encoded. See Figure 9.
Figure 9 Expiration Date and Time
5.1.5
Collection Date [Data Structure 006]
The collection date is not required in all countries. If it is required as text,
there are no additional ISBT 128 requirements to bar code this information. If
desired, however, it can be bar coded. This data structure uses the last three
numbers of the year (e.g., 2017 becomes 017 in the code); the ordinal
number of the calendar year (or Julian date) where the days of the year are
numbered sequentially beginning with 001 on January 1. Data Structure 006
encodes the collection date (see Figure 10). If the collection date and time
are needed, Data Structure 007 should be used (see Figure 11).
Figure 10 Collection Date [Data Structure 006]
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Figure 11 Collection Date and Time [Data Structure 007]
5.2
Reference Tables
Reference tables provide the link between the codes found in data structures and
meaningful information. For the DIN, the link between the assigned code (the DIN) and
the donor, whose blood is labeled with the DIN, is in the facility’s records.
5.2.1
ABO/RhD
For ABO/Rh there are two reference tables, one for when the first two data
content characters encode ABO/Rh and one for when these two characters
encode a special message.
Table 1 Excerpt of ABO/RhD Reference Table for Data Structure 002
ABO and RhD Blood Groups
Code*
O RhD negative
95
O RhD positive
51
A RhD negative
06
A RhD positive
62
B RhD negative
17
B RhD positive
73
AB RhD negative
28
AB RhD positive
84
O
55
A
66
B
77
AB
88
•
This code is used when a special donation type (e.g., autologous,
designated, emergency release) is not encoded within the ABO/Rh.
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See ISBT 128 Standard Technical Specification (ST-001) for other
codes.
Looking back at the example used previously, the “95” in Figure 6, page 21,
would be interpreted as Group O, RhD negative according to the first line in
Table 1.
Figure 12 ABO/RhD Data Structure
O, RhD Negative
If a special message is desired, values found on Table 2 may be used. For
example, if Quarantine/hold for further testing or processing were to be used
instead of an ABO/RhD type, the encoded information would be as shown in
Figure 13, based on the 5th line in Table 2.
Table 2 Special Messages Used in Data Structure 002
Code
Interpretation
00
No ABO or Rh information is available
Mb
Biohazardous
Md
Discard (to be destroyed)
Mf
For fractionation use only
Mq
Quarantine/hold for further testing or
processing
Mr
For research use only
Mx
Not for transfusion based on test results
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Figure 13 Encoding a Special Message
Quarantine/hold for further
testing or processing
Both of these reference tables have more options for coding, including pooled
products and rare ABO groups such as Bombay and paraBombay. There are
also options for encoding the type of collection or release (e.g., for
emergency release).
For complete tables, see the ISBT 128 Standard Technical Specification
(ST-001).
5.2.2
Product Codes
As explained in Section 5.1.3, the Product Code comprises three elements:
the Product Description Code, the Collection Type, and the Divisions Code.
Figure 14 Product Code Data Structure
Product Description Code
For the Product Code [Data Structure 003], there is a very long
and complex reference table called the ISBT 128 Product
Description Code Database that is found in the password
protected area of the ICCBBA Website.
The Product Description Code Database is described in detail in ISBT
128 Standard Product Description Code Database (ST-010).
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Over 8,500 Product Description Codes for blood are listed in this
reference table. These thousands of codes support the many
practices of users of ISBT 128 around the world. Not only are
practices different, but so are regulations. For example,
regulations in some countries require encoding the anticoagulant,
while others do not. In reality, even the most complex of facilities
typically only use a small portion (perhaps 100 or 150) of these
8,500 codes.
Within the ISBT 128 Product Description Code Database, each
product is described by:
•
•
•
•
Class (broad descriptions such as Red Blood Cells and
Whole Blood) (required)
Modifiers (providing the next level of detail such as frozen
or thawed) (optional)
“Core conditions” which are anticoagulant (which can be
unspecified or a specific anticoagulant), intended
collection volume (which can be unspecified or volumes
such as 450 or 500 mL), and storage temperature
(required)
Additional information, called Attributes (e.g., leukocyte
reduced or irradiated) (optional)
These characteristics are listed in the database in a specific order
and separated by specific characters. Modifiers (if present) are
listed first, followed by Class, core conditions, and finally
Attributes. The different characteristics are separated by specific
characters, either a “|” or, between characteristics in the core
conditions, by a “/”. For example, a product description in the
database is shown in Figure 15.
Figure 15 Example Product Description Code
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For more detailed information about Product Description
Coding, see Implementation Guide, Use of the Product Code
[Data Structure 003] – Blood (IG-021).
One of the most important features of ISBT 128 product coding is
that facilities can chose the level of complexity needed by their
own operations and those of their customers. Thus some facilities
may find that fewer than 15 of the more than 8,500 codes are
needed.
ICCBBA recommends that facilities in resource-limited countries
identify and use only those codes that are needed to differentiate
its products. For example, if only one anticoagulant or
anticoagulant/additive system is used within a facility, and only a
few products are produced, perhaps the list of codes in Table 3
is sufficient. As an organization grows, and its product mix
becomes more complex, additional codes may be added.
Table 3 Product Description Codes Reference Table
Product
Description
Code
Product
E8553
WHOLE BLOOD|NS/XX/refg
E8285
RED BLOOD CELLS|NS/XX/refg
E8554
PLASMA|NS/XX/Frozen
E8555
Liquid PLASMA|NS/XX/refg
E8556
PLATELETS|NS/XX/rt
Should more codes be needed, there are two references the user
should consult:
1. Standard Terminology for Medical Products of Human
Origin (ST-002)
2. Implementation Guide: Use of Product Code [Data
Structure 003] – Blood (IG-021)
The latter document also describes a lookup tool that may be
found on the ICCBBA Website that assists the user in selecting
the appropriate code from the thousands found in the database.
Facilities are encouraged to contact the ICCBBA help desk
([email protected]) for assistance with the selection of Product
Description Codes.
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Collection Type
As with other data structures, the reference table for collection
type reflects a wide variety of practices around the world. An
excerpt of this table is shown as Table 4. There is no requirement
to encode the Collection Type and the code “0” may be used
when Collection Type is not needed, as shown in Figure 14.
Table 4 Collection Type
Character
0 (zero)
Type of Collection
Not specified (null value)
V
Volunteer allogeneic
1
For autologous use only
P
Paid allogeneic
C
Replacement
The full reference table for donation type is found in the ISBT
128 Standard Technical Specification (ST-001).
Division Codes
There is no reference table for Division Codes. Assignment of
division codes follow a standardized scheme.
•
If the unit has not been divided, the Division Code is the
default value of 00 (zero, zero).
•
If the unit has been divided, these divisions are encoded in
the Product Code:
The 7th character of the Product Code will encode the
first level division. First level divisions (up to 26) of the
primary collection shall be encoded using capital letters.
The 8th character of the Product Code will encode the
second level division (a division of an already-divided
product). Second level subdivisions (up to 26) shall be
encoded using lower-case letters. See Figure 16 and
Figure 16.
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Figure 16 Example of Division Code
Figure 17 Use of Division Codes for Two Division Levels
For more detailed information about coding of aliquots, see Implementation Guide,
Use of the Product Code [Data Structure 003] – Blood (IG-021).
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6.1
31
Labeling
Electronically-Readable Information
6.1.1
Delivery mechanisms
The delivery mechanism is the means of delivering the electronic information.
Higher capacity delivery systems are available using 2-dimensional or
reduced space symbology bar codes. These codes can carry much more
information in each symbol. More recently the use of radio frequency
identification (RFID) chips that can carry encoded information is being
developed for medical products of human origin.
It is important to recognize that a range of delivery systems can sit at this
level of the hierarchy. The definitions, reference tables, and data structures of
the ISBT 128 information standard can be delivered as easily in a linear bar
code as they can in an RFID tag. The standard is adaptable in order to make
best use of new delivery mechanisms as they are developed.
Linear Bar Codes
Probably the most well-known delivery mechanism is the linear
bar code that has been used in blood transfusion practice for
many years. There are in fact several types of linear bar codes
including the Codabar system that was only capable of encoding
numeric information, and Code 128, a bar code standard widely
used in coding standards such as GS1 and ISBT 128.
2-D Bar Codes
Higher capacity delivery systems are available using 2dimensional symbols. For use on blood labels, the Data Matrix
symbology is required. 2-D symbols can carry much more
information in each symbol and are much more efficient in practice
since a single scan can include all the information normally found
in multiple linear bar codes.
Use of a 2-D symbol requires the use of the Compound Message
[Data Structure 023].
For more information about encoding information into a 2-D
symbol, see Implementation Guide: Use of Data Matrix
Symbols with ISBT 128 (IG-014).
The 2-D symbols may be used in conjunction with linear bar codes
during a time when not all facilities are able to code and decode
information in a Compound Message data structure. Currently
there is a proposal under consideration to utilize only a 2-D
symbol on a blood label. The design of this label is very different
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from the design of a traditional ISBT 128 blood label. Facilities
interested in use of 2-D symbols on blood product labels should
contact the ICCBBA office for more information
([email protected]).
Figure 18 Comparison of 2-D (Data Matrix) and Linear (Code 128)
In Figure 18, the Data Matrix symbol on the left contains the same
information as the 5 linear bar codes on the right.
6.1.2
Concatenation
Concatenation within the ISBT 128 context is the reading of two bar codes as
if they were a single bar code. The ISBT 128 blood component label was
designed to allow two pairs of bar codes to be concatenated:
•
•
The DIN and the ABO/RhD
The Product Code and the Expiration Date and Time
Other pairs of bar codes may be concatenated.
Parameters of scanners have to be appropriately configured to allow
concatenation and software has to support placing the information into the
proper fields. However, once set up concatenation of bar codes can add to
efficiency by allowing a single scan for two bar codes and promote safety by
ensuring the information (e.g., the DIN and ABO/RhD) was scanned from the
same container of blood.
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For more information about concatenation, see:
• ISBT 128 Standard Technical Specification (ST-001);
• Technical Note 2, Length of the Product Code Bar Code
Concatenation (IG-017); and
• Technical Bulletin 5, Bar Code Scanner ISBT 128 Concatenation
(IG-008).
It is possible to concatenate a linear bar code (e.g., a DIN) with a 2-D bar
code to ensure the latter has been applied to the correct unit.
6.1.3
Coding of Information within Electronically-Readable
Symbols
The information within an ISBT 128 electronically-readable symbol is strictly
standardized to allow interoperability between all facilities that use ISBT 128
globally. Information must be encoded as described in Chapter 5 and in the
ISBT 128 Standard Technical Specification.
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6.2
34
Label Design
6.2.1
Role of regulations and other standards
Within many countries, governments regulate the collection, processing, and
testing of blood. There may, therefore, be nationally-specified regulations
governing the labeling of blood. Such regulations take precedence over
requirements and recommendations found in this guidance document.
Similarly, accrediting organizations such as the African Society of Blood
Transfusion and the AABB have standards that indicate what information
must appear on blood labels. Organizations wishing to be accredited by such
organizations must follow the appropriate standards.
6.2.2
Principles
Primary considerations in label design shall include improving the safety of
the product and the efficiency of processing/administering. If these two
considerations conflict, safety shall take precedence over efficiency.
Critical information on the container shall dominate the label via position and
prominence and shall take precedence over information that is of little
importance to the end-user (clinician, nurse, laboratory staff, and other
hospital personnel).
Examples of labels are shown in Appendix 3.
A library of example labels from different countries is posted on the ICCBBA
Website to assist facilities in designing their labels.
6.2.3
Quadrant design
The ISBT 128 label was designed in four quadrants, each 50 mm by 50 mm.
See Figure 19.
The location of each of the 4 major linear bar codes (DIN, ABO/Rh, Product
Code, and Expiration Date and Time) are rigidly defined to ensure the bar
codes may be concatenated. The Collection Date (or Collection Date and
Time) is in the upper left quadrant, but its exact location is not rigidly defined.
See Figure 20.
The specification for the location of bar codes on the label may be found
in ISBT 128 Standard Labeling of Blood Components (ST-005).
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Figure 19 Quadrant Design of Blood Label
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Figure 20 Location of Bar Codes
1. Donation Identification Number
2. ABO/Rh
3. Collection Date or Collection
Date and Time
4. Product Code
5. Expiration Date and Time
Figure 21 ISBT 128 Final Blood Label
Fore detailed information
about label design, see
ISBT 128 Standard
Labeling of Blood
Components (ST-005).
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6.3
37
Text
6.3.1
Eye-Readable Text
Human-readable text corresponding to the information encoded within the bar
codes must appear on the affixed label of the blood product. There are three
types of text on an ISBT 128 label.
Data content
Data content text corresponds to the exact characters within a bar
code, with the exception of the data identifiers. Except for the DIN,
this text appears in small letters left-justified immediately beneath
the bar code. For example, in the blood group label example in
Figure 22, the “1700” immediately beneath the bar code is the
data content text.
Figure 22 Blood Group Label
Bar code
Bar code text is the interpretation of the message within the bar
code into meaningful information. In Figure 22, the “B RhD
Negative” is the bar code text. As explained in 5.2, this information
typically comes from looking up the code in one or more reference
tables.
While the ISBT 128 Standard is very specific about what
information that may be encoded into a bar code and how it is
encoded, bar code text maybe specified by national authorities.
Appropriate standards and regulations should be consulted.
Additionally, the information printed within the bar code text is not
rigidly defined and should be in words that make sense to the
users within a given country, provided the meaning of the words is
consistent with the meaning of the code in the reference table. It
should also be in a language(s) of the country. For example,
Table 4 shows an excerpt from the Type of Collection reference
table.
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Table 5 Excerpt from Type of Collection Reference Table [RT008]
Character
V
C
Type of Collection
Volunteer allogeneic
Replacement
In Africa, where the Africa Society for Blood Transfusion StepWise Accreditation Standards define a Voluntary NonRemunerated Donor, facilities may wish to print “Voluntary NonRemunerated Donation” or a similar phrase when the code “V” is
used within the Product Code. When “C” is selected, they may
wish to print “Replacement Donation” on the label.
Additional Text
Some information on a blood label is not encoded into a bar code
and appears only as text. This is called “additional text.” Warning
messages such as “Properly identify intended recipient” and the
address of the blood collection facility are examples of additional
information. This text should follow national regulations and
requirements of other standards setting organizations.
6.3.2
DIN
Text corresponding to the DIN shall be printed as follows: (1) flag characters
are rotated clockwise by 90 degrees and (2) the manual entry check
character shall appear to the right of the DIN and flag characters and
enclosed in a box (see Figure 23). Care should be taken to use a font which
clearly distinguishes between similar characters (0 and O, I and 1 etc.).
Figure 23 Text Presentation of DIN
Spaces have been inserted in the example in Figure 23 to make the 13character number more easily read by humans. While the example shows a
space between the FIN and the year, and between the year and the
sequence number, this arrangement is not required. National authorities may
decide how the text DIN is displayed. For example, as shown in Figure 24,
the FIN and year may be printed in a smaller font to emphasize the sequence
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39
number and, if the default of 00 is used for flag characters, these characters
do not need to be printed. This design would be appropriate if (1) a single FIN
is used by a BTS and its customers only receive blood products labeled with
this single FIN and (2) the facility does not start over each year with a
sequence number of 000001 (see 5.1.1.1).
Figure 24 Emphasis of Sequence Number in DIN
It is also acceptable to add a space within the sequence number. For
example:
Figure 25 Adding Spaces in Sequence Number
Regardless of the text presentation of the DIN, it is always encoded the same
way within the bar code.
6.3.3
ABO/RhD and Special Message Text
The ABO blood group should be printed as large as space allows. The RhD
type should be printed beneath the ABO group in smaller print. National
regulations and guidelines should be followed.
There are a number of options for RhD negative units that include:
•
•
The ABO Blood Group may be printed as a solid character or as an
outline.
RhD negative can be printed black on white or white on black.
Color coding of ABO blood group is acceptable and is neither encouraged nor
discouraged.
Other formats that follow national guidelines or regulations are also
acceptable. Whatever design is selected, it should be used consistently.
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Figure 26 Group O, RhD Positive Label
Figure 27 Some Options for RhD Negative Labels
Special messages appear in the upper right quadrant in place of the
ABO/RhD. For example:
Figure 28 Example Special Message Label
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6.3.4
41
Product Information Text
As with all bar code text, the wording of product information shall be
consistent with the information encoded within the electronically-readable
information, shall follow national requirements, and shall be in a language
that is appropriate for the users. For example, one country may print “Red
Blood Cells” while another country might print “Erythrocytes.” In general, the
Class name should be more prominent than Modifiers or Attributes.
MODIFIER
CLASS
Attribute
Attribute
For example, text for the product information may appear as:
WASHED
RED BLOOD CELLS
Leukocytes Reduced
SAG-M Added
Store at 2 to 6 C
However, it is again important to note that text is not rigidly prescribed in
ISBT 128 beyond being consistent with the information encoded in the bar
code. Therefore, a different order of the text (e.g., listing the Modifier after the
Class name) and other fonts are acceptable.
6.3.5
Expiry Date and Time Text
The expiry date shall appear in one of two formats:
•
•
Following the ISO 8601 (2004)(E) format (Year, Month, Day
separated by hyphens): 2015-06-24
Day, Month (using a 3-letter abbreviation), year format: 24 JUN 2017.
Expiry time, if relevant, shall be printed based on a 24-hour clock with the
hour and minutes separated by a colon. For example:
2017-06-24 15:15
If the product expires at a default of midnight (for example, the product
expires at midnight on the 35th day), it is not required that the time be printed,
even though it is encoded in the bar code. In this situation, only the expiry
date is printed.
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
6.4
42
Label Options
Labels may be purchased from a commercial printer, may be printed in-house using
appropriate software and hardware, or be a combination of the two. Which of these
method works best depends on the operations of the facility, including how many units
per year it collects. The more blood that is collected, or the greater variety of
components produced, the more likely in-house printing will be best. Additionally, if bar
coding of expiry and/or collection date is desired, then in-house printing of labels is
essential.
Labels should have tamper evidence to reduce the chance of a label being removed and
reapplied, i.e., any tampering with a label should deface the label making it unusable.
Labeling of frozen products may require special label stock capable of adhering to a
frozen product with an irregular surface. Freezing on a flat surface may minimize
irregularities in shape.
6.4.1
Purchasing Preprinted Labels
Many commercial companies offer preprinted ISBT 128 labels. A list of such
companies may be found on the ICCBBA Website. Go to
https://iccbba.org/subject-area/vendors. The Website lists vendors
alphabetically and by product categories. Follow the links to the blood label
companies of interest.
Preprinted DIN Sets
DINs are typically purchased or printed in sets with multiple copies
of the DIN so that a copy of the DIN label may be affixed to each
bag within the collection set, on the donor history questionnaire
form, on sample tubes, etc. Facilities should assess their
processes and ensure their DIN label sets include an appropriate
number of copies of the DIN label.
Piggy Back Labels: Another consideration would be the purchase
of piggy back DIN sets. See Figure 29. Piggy back labels have
two label layers and one liner. (1) The top layer has the DIN on
the front and adhesive on the back. (2) The second layer has a
release coating on the front (to which the top layer is attached)
and adhesive on the back. The adhesive attaches the second
label layer to the liner. (3) The liner holds the two label layers and
provides the support so the label set can be manufactured into
rolls or tablets. When ready to use, the label set (both layers) is
pulled off the liner and attached to the back of the blood bag. The
top label (with a DIN) can be pulled off when needed. This allows
extra DIN labels to be attached to the blood bag and used either
by the BTS or the HBB later in the process.
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Figure 29 Piggy Back DIN Labels
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44
Tear-off Labels
Tear-off Labels: Tear-off labels are another option. See Figure
30. The tear-off portion has a backing that is removed to reveal
the adhesive. The adhesive on the tear-off portion is used to apply
the label to a recipient record.
Figure 30 Tear-Off Label
This portion of the
label may be torn
off and placed in
the blood
recipient’s medical
record.
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45
It may be possible to order preprinted sets of DINs. There are
several considerations if this method is chosen.
(1) How many DINs are needed within a set? Each product from a
collection (e.g., red cells and plasma) will need a DIN label, as
will each sample tubes and the donor history document.
Therefore a facility will need to determine how many DINs it
will need for each collection. Ordering unnecessary DINs
increases costs and increases likelihood that DIN label may be
used on an inappropriate item. Ordering too few DINs may
result in hand written information where a more legible printed
version would be more desirable.
(2) Because the year of collection is encoded in the DIN, facilities
must estimate how many collections will occur in a given year.
While there is a one-month tolerance (that is, “17” may be
used from 1 December 2016 through 31 January 2018), the
facility must approximate how many DIN will be needed each
year.
(3) A DIN must be unique. A system must exist to ensure the
same DIN is never ordered and used twice.
A facility can determine the sequence number. It may make sense
for one facility to start at 000001 each year, but for another facility
it may make sense to number continuously from 000001 to
999999 over several years. See section 5.1.1.1.
Upper Left Quadrant
The DIN is usually ordered as a separate label and the rest of the
upper left quadrant may be ordered as a preprinted 50 mm by 50
mm label. The content of this label will depend on national
requirements, but will likely include the name and the address of
the facility and may contain various informational or warning
messages (e.g., “Voluntary, Non-Remunerated Donor” or
“Properly identify intended recipient”). See Figure 31.
Figure 31 Preprinted Upper Left Quadrant
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46
This label may be placed on the bag as soon as it is removed from
its packaging. Prior to collection of blood, the DIN should be
added to this label. The collection date, if desired, could be added
at any time before or during final labeling. See Figure 32.
Figure 32 Upper Left Quadrant after Addition of DIN and Collection Date
Alternatively, the full 100 mm by 100 mm label be ordered with only the
information shown in Figure 33. This provides a base onto which the DIN and
the other 50 mm by 50 mm quadrant labels can be affixed.
Figure 33 100 mm by 100 mm Initial Label
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47
Upper Right (ABO/Rh) Quadrant
ABO/Rh and special message labels may be ordered preprinted.
See Figure 40. If preprinted labels are used, consideration can be
given to color coding different ABO groups.
Figure 34 Preprinted Upper Right Quadrant Label
Lower Left (Product) Quadrant
Ordering preprinted labels for the lower left quadrant (see Figure
35) works best when relatively few products are being produced.
One means to reduce the number of different types of labels to
order is to use Product Description Codes that utilize more generic
descriptions such as “not specified” for anticoagulant. The actual
anticoagulant may not be needed on the label, or, if required, it
may be handwritten in a blank space provided. Likewise, a
Product Description Code with the nominal collection volume
encoded as “not specified” may be used and the actual nominal
collection volume (e.g., 250, 350, 450 or 500 mL) may not be
necessary or may be handwritten on the label. See Figure 35 and
Figure 36.
Figure 35 Preprinted Lower Left Quadrant
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Figure 36 Lower Left Quadrant with Handwritten Information
Lower Right Quadrant (Expiration Date/Time and Special
Testing):
The lower right quadrant comprises two significant types of
information: the expiry date and time and the results of special
testing such as CMV and Hemoglobin S. See Figure 37.
It is not practical to order bar coded expiry date or date/time labels
so if preprinted labels are used, handwritten or rubber stamped
expiry dates and times could be used. If rubber-stamped, small
label stock could be used. The inks used should be validated to
ensure that the ink is indelible and does not smear.
It may be possible to order preprinted labels for CMV negative or
Hemoglobin S negative labels, if these are needed.
Figure 37 Lower Right Quadrant
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Figure 38 Use of Preprinted Labels
Preprinted labels can be purchased and assembled to create a final label. Below, a 100 mm x 100 mm base label is purchased and
applied to the unit prior to collection. This label contains the text identification of the collection center, the statement “VOLUNTARY NONREMUNERATED DONATION, and the text for collection date and expiration date. At the time of collection, the DIN label is added. This will
likely come from a set, as shown in Figure 29, page 43. Then, a product code label is applied. If the product is whole blood, this can be
applied at the time of collection. If the product is packed red blood cells, plasma, or platelets, it can be affixed when the component is
made. Expiration dates are rubber-stamped onto blank label stock. The ABO/Rh may be applied when all testing is completed, as the final
labeling step. See Figure 39, page 49. When completed, the label will appear as in Figure 40, page 50.
Figure 39 Assembly of Preprinted Labels
Base label
2016-01-02
2016-02-06
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Figure 40 Label Created Using Preprinted Quadrant Labels
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Control of labels
It is important to properly control preprinted labels. New labels
should be examined upon receipt to ensure they are correct and
meet the needs of the facility. When a label design is changed, old
labels with the former design must be discarded so they are no
longer available for inadvertent use.
As noted above, DIN labels must be carefully controlled to ensure
the same DIN is never used on different collections.
Additionally, consideration should be given to physically
controlling labels to ensure they are not available for inappropriate
use. For example, DIN sets available in a donor room should be
only those appropriate for assignment to donors whose blood is
collected in that location. If personnel working in a components
laboratory should never change a DIN, making DIN sets
unavailable in the components laboratory would enforce the
policy.
6.4.2
On-Demand Labels
On-demand labels are those that are printed as needed within the facility.
This requires appropriate printers, software, and supplies such as label stock.
Many commercial companies offer software programs that produce ISBT 128
labels. A list of such companies may be found on the ICCBBA Website. Go to
https://iccbba.org/subject-area/vendors. The Website lists vendors
alphabetically and by product categories.
Excellent sources of information about selecting printers and evaluating
the quality of bar codes can be found in two references:
• Implementation Guide: Choosing an On-Demand Label Printer
(IG-029)
• ISBT 128, An Introduction to Bar Coding (IN-009)
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Use of On-Demand Labels
Software can be part of an integrated system that manages donor
information, component production, laboratory testing, and
distribution/traceability information or it may be a stand-alone
system that simply produces labels based on user input. Which of
these options is best must be determined by each facility. The
decision depends on such things as the volume of collections, the
budgetary resources available, and the degree of automation
desirable.
Integrated systems allow the user to print labels based on
information within the Laboratory Information System. A Product
Code label (usually preprinted) would need to be added at the
time of component preparation. Thereafter, integrated systems
allow users to simply scan the DIN and product code and the
system will print an appropriate label.
Stand-alone systems may have general label software or may be
specific to ISBT 128. Options 2 and 3 on the chart in Appendix 2
describe these two options. For the general label software, users
may need to select from pre-established templates and these
templates may not include the option for printing highly variable
data, such as expiry dates. For ISBT 128-specific software, users
must enter the appropriate data for each unit in order to print a
correct label.
DINs may be printed as described in Section 6.4.1.1 on
appropriate label stock, although piggyback and tear-off stock may
not be available in all locations. DINs are often printed in advance
of need.
Labeling Process: With on-demand labels, a 100 mm x 100 mm
label is typically printed that has everything except the DIN. The
blank label stock may have a dye-cut (or cutout) in the upper left
corner to allow the DIN to be visible after the printed label is
applied. See Figure 41. If such a cutout is not present, strong
controls must be in place to ensure the correct label is applied.
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Figure 41 Labeling Using 100 mm x 100 mm “Over-lay” Label
The label on the left (beneath the label with the ABO RhD) is the base label after the DIN has been applied. On the right is a 100 mm x
100 mm over-lay label. There is a “cutout” in the upper left corner so that the DIN will not be over-labeled. The over-lay label could be
created using general label software or ISBT 128-specific software and affixed over the base label.
Pre-printed
DIN Label
(applied at
collection to
the base
label)
Base Label
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100 mm x 100 mm
over-lay label
(applied at the time
the unit is ready for
release)
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Control of software/validation
Label software, whether stand-alone or integrated, needs to be
validated to ensure it will consistently produce an outcome
meeting its predetermined specifications and quality attributes. If
used in more than one location, validated software should be
verified to ensure it works in the additional location(s). When
software is updated, revalidation/reverification should be
performed.
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7
7.1
55
ISBT 128 in the Hospital Blood Bank
Essential Records
Enough information from the product label must be recorded in facility records to ensure
traceability and safety. One of the advantages of ISBT 128 is that the location of critical
information is very consistent across all suppliers and blood products.
7.1.1
DIN
The full DIN is 13-characters comprising the Facility Identification Number, a
year code, and a sequence number. At the end of the DIN, within a box, will
be a check character. Between the DIN and the check character, there may
also be “flag characters” printed at a 90 degree angle from the DIN. See
Figure 42.
.
Figure 42 Donation Identification Number
On the label, the DIN appears in the upper left portion of the label.
Figure 43 Location of DIN on ISBT 128 Label
DIN Bar Code
DIN Text
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DIN Labels
Some blood suppliers may provide copies of DIN labels on the
back of the blood bag, as shown in Figure 29, page 43. In this
situation, a label may be peeled from the bag and placed into
facility records.
Alternatively, DIN labels may be provided as tear-off portions of
the label on the front of the bag. The backing on the tear-off
portion has a backing that is removed to reveal the adhesive.
Figure 44 Label with Tear-Off Portion for Patient Record
Tear-off Portion
of Label to be
affixed to the
patient’s
medical record.
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7.1.2
57
Product Information
Because more than one product may be made from each collection, it is
important to keep a record of which component was received and transfused.
Thus, in addition to the DIN, records must include product information which
is found in the lower left portion of the label. In the HBB that has scanners
and a computer system that reads, interprets, and records ISBT 128 data
structures, this is done by scanning the product code.
Figure 45 Location of Product Information on ISBT 128 Label
Product Code Bar Code
Product Code
Product Description
If the HBB maintains manual records, it must record enough information to
ensure each component may be traced. An HBB should discuss with their
blood supplier how much information must be recorded. It is quite possible
only the Class of the product (e.g., Red Blood Cells, Plasma, or Platelets)
needs to be recorded. This will depend on the complexity of the supplier’s
operations. For example, if the blood supplier provides multiple products of a
given Class (e.g., multiple plasma units) from a given collection, more
information must be recorded.
If pediatric aliquots are made, the Division Code of the aliquot must be
recorded in facility records. Within ISBT 128 this will appear as the last 2
characters of the Product Code (found immediately below the Product Code
bar code) as well as within product description text. This will usually appear
as a combination of numbers and letters. When a product is not divided, the
last 2 characters of the product code will be 00 (zero, zero). If the product has
been divided (for example, for use for pediatric patients), the first of these two
zeroes will change to an upper case letter. That is, the code will change from
00 to A0, B0, C0, etc., numbering each product successively. Should one of
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58
the divisions be further divided, the second zero will change to a lower case
letter. That is, the code will change from A0 to Aa and Ab or from B0 to Ba
and Bb.
While the precise position of the division code text or the exact words may
vary, text identifying product divisions this should appear in the lower left
quadrant of the label as shown in Figure 46.
Figure 46 Location of Product Division Information on ISBT 128 Label
Last two characters of the Product
Code are A0 indicating a divided
product.
Last two characters of the Product
Code are A0 indicating a divided
product.
7.1.3
ABO/RhD
While not needed for traceability, the ABO and RhD type of the unit should be
recorded in facility records. This information is found in the upper right portion
of the ISBT 128 label. See Figure 46.
7.1.4
Expiry date
It is also recommended that the expiry date (and time, if an expiry time is
included on the label) be recorded. This information is found in the lower right
portion of the label. See Figure 47.
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Figure 47 Placement of ABO/Rh and Expiry Date
ABO and RhD
Expiry Date
(or Expiry
Date and
Time)
7.1.5
Linking Product Information to Recipient Information
Facility records should also link the DIN and product information with the
name and identification number of the patient who received the product. This
is generally done in two places: a log created as units are received
(chronological record) and in a patient record.
7.2
Modification of Products
HBBs may modify products; thawing frozen products, pooling platelets, and dividing
products for pediatric patients are probably the most common. It is not required that
ISBT 128 be used to re-label such modified products, but a facility (especially one with a
sophisticated computer system) may choose to do so. Facilities that apply ISBT 128 bar
codes should be registered with ICCBBA and pay an annual licensing fee.
For information about registration and licensing with ICCBBA, see Chapter 10 and
the Registration and Licensing section of the ICCBBA Website (www.iccbba.org).
You may also email the help desk at [email protected].
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7.2.1
60
Expiry Dates
If the expiry date changes because of a modification, the expiry date on the
label must be changed to reflect the new expiry date (or expiry date and
time). This can be a handwritten correction following appropriate procedures
or a new label may be applied over the old label.
7.2.2
Product Code
Thawed Plasma: Changing the product code/description on a unit of thawed
plasma is not required. Simply changing the expiration date is adequate.
If an HBB wishes to re-label with ISBT 128, it may change the lower half of
the label to reflect both a thawed plasma product code and the new expiry
date and time. This may be done by over-labeling with a preprinted lower left
quadrant label (Product Code) and handwritten correction to the lower right
quadrant.
If the facility is able to print labels, a label stock that is 100 mm by 50 mm that
can overlay the bottom half of the plasma label may be used. See Figure 46,
page 58.
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Figure 48 Replacing Lower Half of the Label for Thawed Plasma
New label for product information
and expiry date and time.
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62
ISBT 128 has many product codes for modified products. The ICCBBA
Website provides a lookup tool for Product Description Codes that may be
downloaded onto a local computer. This is found at www.iccbba.org under
the “Lookup Tool” tab, then “Find Product Information.”
Pooled Products: HBBs are not required to use ISBT 128 labeling on pooled
products such as Pooled Platelets. They may simply pool all selected
products and label the bag with non-ISBT 128 labels. Records should
indicate which products (DIN plus product) are in the pooled product.
If an HBB choses to relabel with ISBT 128, a unique DIN (pool number)
should be assigned to the pool and a pooled Product Description Code
should be selected. For example, E2897 is Pooled Platelets stored at 20 to
24 C. Neither the anticoagulant nor the nominal collection volume are
specified for this Product Description Code.
Divided Products: If the facility chooses to label with ISBT 128, as noted in
5.2.2.3, the division code is the last two characters of the 8-character Product
Code. The 7th character denotes a first level division; the 8th character a
division of an already divided product.
Details on dividing products may be found in Chapter 5 of Implementation
Guide, Use of Product Code [Data Structure 003] – Blood (IG-021)
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63
Back-up Systems
A backup labeling system must be planned to ensure continued operation in the event of a
power failure, equipment failure, or other interruption. There must be SOPs, training, and
regular tests of the backup system to ensure it will work when needed.
For DINs, an inventory of an adequate number of labels for anticipated down time should be
available. If the facility prints its own labels, this generally means routinely having a dynamic
inventory that continually runs a few days in advance of need.
Options include:
• Maintain an inventory of preprinted labels to be used in the manner described in 6.4.1.
• If using on-demand labels, retain an adequate stock of preprinted labels to be used in
the event of down time.
• Collection and expiration time labels cannot be created in advance, so a backup system
for including this information is needed. The backups system may not allow for bar
coding this information.
Having more than one scanner and printer will eliminate some downtime
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
9
64
Hemovigilance
Hemovigilance is the monitoring of blood transfusions and their complications with the aim of
improving the quality and safety of transfusion. It involves continuous data collection and
analysis of transfusion-related adverse events and reactions, as well as investigation of causes
and outcomes, to prevent occurrence or recurrence.
In November of 2012, the WHO, the International Haemovigilance Network, and the
International Society of Blood Transfusion, held a Global Consultation on Haemovigilance. At
the conclusion of the conference, the group published recommendations
(http://www.who.int/bloodsafety/haemovigilance/global_consultation/en/) for the different levels
within a transfusion medicine chain: the Hospital/Institution, National, and International. Among
these recommendations were two that specifically addressed traceability:
For the hospital/institution level:
“Define quality indications as measures of clinical practice and traceability including confirmation
of transfusions; and collect and analyze the indicators data on regular basis for quality
improvement.”
For the national level (blood transfusion services):
“Secure traceability (bidirectional tracking from donor to transfused patient and vice versa (vein
to vein, using appropriate IT and communication tools).”
ISBT 128 supports hemovigilance in a number of ways:
•
•
•
By providing electronically-readable critical information on blood labels, record keeping
becomes more accurate and efficient.
Standardized terminology supports comparing data from multiple organizations.
Product Description Codes (PDCs) provide a wealth of information useful to analysis of
data. Software may be developed to help hemovigilance organization mine the data
available from PDCs.
On its Website, WHO recognizes that ISBT 128 is the sole system for coding and labeling of
MPHO (http://www.who.int/transplantation/tra_isbt/en/ )
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10 Registration and Licensing with ICCBBA
Facilities wishing to use ISBT 128 by applying ISBT 128 bar codes must register with ICCBBA.
Information about this process and a registration form may be found on the ICCBBA Website
(http://www.iccbba.org/registration-licensing). The cost of registration and licensing is reduced
for facilities that are located in countries with a Human Development Index (HDI) classification
of Medium or Low. For facilities in Low HDI countries, the fees are 33% of the normal amounts
indicated on the ICCBBA Website. Information about HDI may be found at
http://hdr.undp.org/en/composite/HDI.
Fees support ICCBBA’s management of the ISBT 128 Standard—databases, documents, help
desk, educational activities, etc. ICCBBA does not provide software or hardware used with the
ISBT 128 Standard. ICCBBA-licensed vendors provide software that utilizes ISBT 128. A list of
such vendors can be found on the ICCBBA Website.
Once a facility is registered, it will be assigned a Facility Identification Number (FIN) that may be
used within the DIN to uniquely identify products.
There is flexibility in how facilities owned and operated by the same organization with multiple
sites may use FINs. Facilities with multiple locations may opt to have a single FIN and manage
the sequence number allocation across all of their locations centrally, or they may request
multiple FINs with each facility controlling its own sequence number allocation.
•
•
It is recommended that an organization with a single processing center, but multiple
collection locations, have a single Facility Identification Number (FIN).
It is recommended that an organization with multiple processing centers request a
different FIN for each location. While each location can have a different FIN, registration
can be as a single organization or each location can register separately.
Please contact the ICCBBA help desk ([email protected]) for more information.
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11 Conclusion
11.1 Flexibility
ISBT 128 is a highly flexible system. It can be kept simple with a few basic Product
Description Codes and preprinted labels. As the complexity of a facility grows, additional
features of ISBT 128 can be implemented and greater automation of the labeling system
can be introduced.
Appendix 1 provides a basic implementation plan. Step 4 of this plan requires a facility to
identify its automation needs. Appendix 2 goes into detail of the options available to
complete Step 4.
11.2 More information and technical support
A great deal of information may be found on the ICCBBA Website (www.iccbba.org).
Information on registration, as well as technical information, is available.
ICCBBA provides technical and registration support for those considering or
implementing ISBT 128. This support is available through the ICCBBA help desk (email
[email protected]). The staff are based near Los Angeles, California, USA, and are
therefore in the Pacific time zone (-8 GMT).
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Acronyms
2-D
Two-dimensional
AfSBT
Africa Society for Blood Transfusion
BTS
Blood Transfusion Service
DIN
Donation Identification Number
FIN
Facility Identification Number
EMATAG
Europe, Middle East and Africa Technical Advisory Group
HDI
Human Development Index
HBB
Hospital Blood Bank
IEC
International Electrotechnical Commission
ICCBBA
International Council for Commonality in Blood Bank Automation
ISO
International Standards Organization
MPHO
Medical Products of Human Origin
PDC
Product Description Code
RFID
Radio Frequency Identification
WHO
World Health Organization
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Glossary
Bar code
A symbolic representation of a data structure that also includes the
symbology-specific start and stop codes.
Linear bar
code
Single row of bars and spaces
2-D bar code
Two-dimensional pattern of data cells
In this document the unqualified use of linear bar
code implies the use of Code 128 symbology with
its associated modulo 103 check character.
In this document the unqualified use of 2-D bar
code implies the use of Data Matrix.
Blood
Transfusion
Service (BTS)
An organization, or department within an organization, that is responsible
for any aspect of the collection and testing of human blood or blood
components, whatever their intended processing, storage, and
distribution when intended for transfusion (excludes hospital blood bank).
Check
character
A character used to ensure the accuracy of data. The value is calculated
based on an algorithm applied to the data. Examples are the modulo 103
check character internal to Code 128 and the ISO/IEC 7064 modulo 37-2
check character appended to data content text that verifies accurate
keyboard entry.
Concatenation
A method by which the information held in two bar codes is combined in
the scanner into a single string of data before being sent to the host
computer. ISBT 128 places specific rules on the operation of
concatenation which ensures that the two codes are adjacent to one
another, hence allowing this feature to be used in label process control.
(Note: ISBT 128 concatenation is a specific enhancement to the Code
128 Specification. See Section 6.1.2, page 32.)
Data character
The individual ASCII characters that make up the data content.
Data content
The characters in a data structure that encode the information for which
the data structure is named. The data content does not include the data
identifier. (The Donation Identification Number is an exception to this
rule. See Section 5.1.1, page 18.)
Data identifier
The first two or three characters in a data structure that identify the data
structure. These will always be present when the data structure is used
as a bar code, but may be omitted when the data structure is used in
situations in which the data structure identity is unambiguously and
explicitly defined. (The Donation Identification Number is an exception to
this rule. The second character of the data identifier can never be
dropped because it is also part of the data content. See Section 5.1.1,
page 18.)
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Data structure
Information content comprising the data identifier and data content.
When a data structure is represented as a bar code, the term data
structure does not include the symbology-specific and always-present
start and stop codes, the modulo 103 check character, or any specified
control characters.
Division Code
A code assigned to blood products that has the same Donation
Identification Number (DIN) and Product Code to provide unique
identification.
Donation
Identification
Number (DIN)
A globally unique identifier that is assigned to each collection and to each
pooled product. When used on a collection, the DIN is used to link the
collected product to the donor.
Europe, Middle
East and Africa
Technical
Advisory Group
(EMATAG)
A group of experts from countries within Europe, the Middle East, and
Africa that advise ICCBBA on labeling, coding and terminology needs of
blood facilities in countries within these regions.
Collection Type
A designation indicating why a product was collected
Autologous
Designated
Directed
A product collected from an individual for his or her own
use.
A special product (for example, HLA-compatible)
collected through an arrangement by the collecting
facility to be used by a specific recipient (or for Cellular
Therapy products, possibly a small group of recipients).
A product collected from an individual who presents to
the collecting facility at the request of another person
intending his/her product to be used by that person.
Facility
An organization that is responsible for the collection/recovery,
processing, and/or distribution of ISBT 128-encoded products.
Facility
Identification
Number (FIN)
A five-character alpha numeric code assigned by ICCBBA to licensed
facilities. It can be used in a variety of ways to ensure uniqueness of an
identification number.
Flag character
Part of the data content of a data structure used in process control or
data transmission checking. For ISBT 128, flag characters are used with
the Donation Identification Number. The characters are printed in eyereadable format and distinguished in some manner from the
representation of the other data characters.
Hemovigilance
A set of surveillance procedures covering the whole transfusion chain
from the collection of blood and its components to the follow up of its
recipients, intended to collect and access information on unexpected or
undesirable effects resulting from the therapeutic use of labile blood
products, and to prevent their occurrence and recurrence.
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Hospital blood
bank (HBB)
A hospital unit which stores and distributes, and may perform
compatibility tests on, blood and blood components exclusively for use
within hospital facilities. It includes hospital-based transfusion activities.
An HBB may also be referred to as hospital transfusion laboratory.
Interoperability
A characteristic of systems (including coding systems such as ISBT 128)
that allows them to work with other products or systems without
restrictions.
ISBT 128
An international standard for the transfer of information associated with
medical products of human origin. It provides for a globally unique
donation numbering system, internationally standardized product
definitions, and standard data structures for bar coding and electronic
data interchange.
Julian Date
See Ordinal Number.
Label
An independent entity that may carry one or more bar codes and also
provides eye-readable information about the product.
Affixed label
A label that adheres in physical contact with the
product container.
Base label
The label placed on a container by a manufacturer.
It carries the manufacturer’s identity, the catalog
number of the container (or container set), and the
lot number of the container (or container set)
encoded as ISBT 128 data structures OR an initial
label applied by the facility to which additional labels
will be applied.
Final label
Labeling as it appears on a product ready for
release to another entity or for administration to a
recipient.
Medical
Products of
Human Origin
(MPHO)
Products derived from a human source that are intended for therapeutic
use in a human. They include blood, organs, bone marrow, cord blood,
ocular tissue, tissues, reproductive cells, and milk.
Ordinal Number
A number within the calendar year used in a system for maintaining
dates that numbers the first day of the year (January 1) as 1 and the last
(December 31) as 365 or 366 (in a leap year). Also known as Julian
Date.
Product Coding
The following terms are used in describing products within ISBT 128.
Attribute
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An level of terminology that provides the most
detailed information about a product (e.g., irradiation
or plasma reduced)
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Radio
Frequency
Identification
(RFID)
71
Class
A broad description of a product (e.g., Red Blood
Cells or Platelets)
Modifier
An intermediate level of terminology that provides
information primarily about the physical state of a
product (e.g., frozen, deglycerolized, thawed).
Product
Description
Code (PDC)
A code assigned to products. Each product
comprises a unique combination of Class, Modifier,
and Attributes within the ISBT 128 system.
The use of electromagnetic fields to automatically identify and track tags
attached to objects.
Surveillance
In the context of transfusion and transplantation, the close and
continuous monitoring of outcomes.
Text
The following terms are used within ISBT 128 to describe label text.
Data content text
(previously
called eyereadable text)
The eye-readable representation of the data
characters in a bar code (printed left justified
immediately below the bar code, unless otherwise
specified).
Bar code text
The interpretation into meaningful information of the
data content of the bar code.
Additional text
All other information on the label that is not
associated with a bar code.
Traceability
The ability to verify the history, location, or application of an item
by means of documented recorded identification.
Vigilance
A comprehensive and integrated patient safety program to collect,
analyze, and report on the outcome of collection and transfusion and/or
transplantation of blood components and derivatives, cells, tissues, and
organs.
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Appendix 1 Example Implementation Plan
The following example plan was meant to be comprehensive, and not all steps may be needed
by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider
rather than attempting to follow it precisely.
Step
1.
Activity
Form team
a. Identify leader
b. Identify team members (IT, Quality, Laboratory, Processing,
Recovery/Collections, Product Management)
2.
Register with ICCBBA
a. Obtain FIN
b. Obtain password to access to all documents and databases
c. Subscribe to update notification service
3.
Become familiar with resources and identify changes that are needed.
a. Explore ICCBBA Website
b. Assemble and review documents and implementation tools
c. Utilize ICCBBA help desk ([email protected])
4.
Identify equipment/software needs
a. Determine specifications
b. Assess current software and equipment against needs
c. Determine if organization will need to upgrade or replace software and
equipment
d. If new software or equipment is needed, analyze alternatives
5.
Obtain funding
a. Determine resources needed and their cost
b. Create budget plan
c. Request funding
6.
Upgrade or purchase equipment/software, if needed
7.
Develop and approve plans
a. Project/implementation/change control plan(s)
b. Transition plan
i. Determine how dual-labeled inventory will be managed
ii. Determine how conversion will the coordinated with testing laboratory and
facilities that will receive products
c. Validation plan
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Step
8.
73
Activity
Perform IT-related operational steps
a. Plan product coding
i. Map products from current coding to ISBT 128
ii. Request new codes where appropriate codes are not available
b. Populate computer tables
c. Validate software, equipment, processes, and labels
9.
Update/create/approve documentation
a.
b.
c.
d.
e.
Label design
SOPs and work instructions
Quality plan
Training materials for staff
Educational materials for those who will receive products
10. Communicate
a. Notify testing laboratories and other affected suppliers of the changes to
sample and product identification
b. Train staff
c. Provide educational sessions for those who will receive products
d. Notify competent authorities, if required
11. Implement ISBT 128
12. Assess results and opportunities for improvement
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Appendix 2 Options for Implementing ISBT 128
The following table is informational only. It is not intended to recommend a specific course of action. Reference to any
particular vendor is not an endorsement of that vendor’s products and other suitable vendors may also be available.
Options:
1. Preprinted
Label
•
•
•
•
2. General
labeling,
Stand-alone
software
program for
general
labeling
•
•
•
•
•
Advantages
No equipment
maintenance
Low cost for start-up
Short start-up time
Once approved by
facility’s Quality
Department (and
verified by ICCBBA, if
desired), the labels can
be used by trained staff.
Lower cost for software
Can produce a large
variety of different labels
Templates can be
created so that a label
may be designed in
advance by Quality or IT
staff.
Different vendors, and
editions from a given
vendor, are available to
increase flexibility of the
system.
There is global technical
support available from
some suppliers. This
would be limited to the
use of the software, and
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Disadvantages
• May not be available
from a local supplier
making reliably
receiving supplies a
problem
• Cannot bar code the
expiry or collection
dates
Comments
Facility would probably need to
find a supplier within their region
that could produce these labels.
• Requires high level
of knowledge of
ISBT 128 Standard.
The software does
not have the logic to
create ISBT 128 bar
codes from userfriendly input (i.e.,
you cannot enter 25
June 2017 and have
the system encode it
properly).
• Time-consuming to
set up label
templates
• Some such software
is not scalable for
multiple centers with
• Because use of this software
requires someone with a high
level of knowledge about ISBT
128, it may not be practical
across the entire system unless
versions with greater flexibility
are chosen.
• A template for each product,
and each ABO/Rh, could be
developed. Users would have to
select the right template (e.g.,
Platelets that are A, RhD
positive).
• Bar coding the expiry and
collection dates would be
difficult with some versions of
this software. These dates
could not be encoded within the
•
•
•
Costs*
Variable,
depending on
volume.
Scanners
Relative cost: $
Example costs:
• Printer(s)
• Blank label
stock
• Ribbons for
printer
• Licenses may
be based on the
number of
computer
stations or the
number of
printers.
• Scanner(s)
• Relative cost:
$$
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Use of ISBT 128 in Resource-Limited Countries v1.0.0
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The following table is informational only. It is not intended to recommend a specific course of action. Reference to any
particular vendor is not an endorsement of that vendor’s products and other suitable vendors may also be available.
would not cover ISBT
128 label-specific
support.
3. Stand-alone
software,
with specific
ISBT 128
functionality.
• Vendor takes
responsibility for
compliance with ISBT
128 standard
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central control.
Software that is
scalable may be
more expensive.
template because the
information would change each
day and with each type of
product. The date encoded in
the bar code is the last 3
characters of the year (e.g.,
2017 is encoded 017) and the
ordinal number/Julian date.
Thus, it is in a different format
from the eye-readable date
which is either DD MMM YYYY
(08 JAN 2017) or YYYY-MMDD (2017-01-08). This could
create a source of error if the
bar coded date does not match
the eye-readable date. Eyereadable only dates might be
necessary. A printed date that
could be added to the label, or
a rubber stamp dating, might
work best.
• Facilities would need to ensure
software allows “locking” of
template so users cannot
change the template
inadvertently.
• May be “overkill” for
the number of
different products
produced
• Some systems are stand-alone
and some may be interfaced to
a laboratory system.
Example costs:
• Printer(s)
• Blank Label
stock
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The following table is informational only. It is not intended to recommend a specific course of action. Reference to any
particular vendor is not an endorsement of that vendor’s products and other suitable vendors may also be available.
4. Integrated
software
package
• Users select product
label data from
dropdown menus. For
example, they select the
Product Description
Code and the blood
group/type from
dropdown menus to
create the label. The
software then encodes
the information and
prints a correct ISBT
128 label.
• Users enter the correct
date in user-friendly
manner and the
software creates the
correct bar code as well
as the correct text. This
allows expiry date to be
bar coded.
• Scalable for additional
locations. Once set up,
the equipment should be
easy for anyone to use.
• Greatest benefits and
safety improvement
• ISBT 128 is just one
piece of a complex
program to support
computer control of
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• There are not a
large number of
companies providing
this software.
Technical support
may not be available
near the facility and
may only be by
telephone/email.
• Ribbons for
printer
• Annual
license/support:
• Scanner cost
• Relative cost:
$$$
• Long start-up time
• Greatest cost
• Often requires many
months of learning,
validation, training,
etc.
• Printer(s)
• Blank label stock
• Ribbons for
printer
• Scanner(s)
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The following table is informational only. It is not intended to recommend a specific course of action. Reference to any
particular vendor is not an endorsement of that vendor’s products and other suitable vendors may also be available.
critical steps in a blood
banking
• High maintenance
(backups,
emergency power,
controlled shut
down, etc.)
• May need additional
labeling software
with ISBT 128
functionality
• There may be
annual maintenance
costs
• Annual
license/support
• Relative cost:
$$$$
*Costs are very approximate and based on quotes obtained in the US. The cost in other countries may vary and would need to be
investigated. If not purchasing locally, shipping costs would need to be evaluated.
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Appendix 3 Example Labels
Figure 49 Full Label
Figure 50 Examples of Upper Right Quadrant
Examples of RhD Negative labels are shown as Figure 27 on page 40.
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Figure 51 Examples of Lower Left Quadrant Labels
Figure 52 Examples of Lower Right Quadrant Labels
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